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Manish A. Shah, MD, on Gastric Cancer: Results From the RAINFALL Trial
Manish A. Shah, MD, of Weill Cornell Medicine, discusses phase III study findings on cisplatin plus capecitabine or fluorouracil with or without ramucirumab as first-line therapy in patients with metastatic gastric or gastroesophageal junction adenocarcinoma (Abstract 5).
Khaldoun Almhanna, MD, MPH, on Gastric Cancer: Results From the CCOG 1102 Trial
Khaldoun Almhanna, MD, MPH, of the H. Lee Moffitt Cancer Center, discusses the long-term outcome of a phase III study that explored the significance of extensive intraoperative peritoneal lavage in addition to standard treatment for ≥ T3 resectable gastric cancer (Abstract 1).
Ghassan K. Abou-Alfa, MD, on HCC: Results From the CELESTIAL Trial
Ghassan K. Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III study findings on cabozantinib vs placebo in patients with advanced hepatocellular carcinoma who have received prior treatment with sorafenib (Abstract 207).
2018 GI CANCERS SYMPOSIUM: First-Line Ramucirumab in Gastric Cancer Improves Progression-Free but Not Overall Survival
The monoclonal antibody ramucirumab (Cyramza) was evaluated as first-line therapy for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma in the international phase III RAINFALL trial. Charles Fuchs, MD, of Yale New Haven Health in Connecticut, presented findings...
2018 GI CANCERS SYMPOSIUM: Cabozantinib Demonstrates Significant Overall Survival Benefit in Patients With Previously Treated Advanced HCC
Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...
Expert Point of View: Robert Brodsky, MD and Henry Fung, MD, FACP, FRCPE
“Several new drugs that have been approved for the treatment of chronic lymphocytic leukemia (CLL) are changing the landscape of this disease. CLL is associated with a long survival, so we will need longer follow-up to see how deep the responses are,” said Robert Brodsky, MD, Director of...
Venetoclax Plus Rituximab Outperforms Standard Bendamustine Plus Rituximab in CLL
Venetoclax (Venclexta) plus rituximab (Rituxan)—a non–chemotherapy-containing regimen—was superior to standard-of-care bendamustine plus rituximab for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a final analysis of the phase III MURANO study reported at...
Best Outcomes to Date in Older Patients With Hodgkin Lymphoma
Older patients with Hodgkin lymphoma typically do not fare as well as younger patients on standard regimens. A phase II study reported the best outcomes to date in older patients with Hodgkin lymphoma who were treated with sequential brentuximab vedotin (Adcetris) before and after a regimen of...
Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma
Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...
Study Findings on Novel Therapies for Hematologic Malignancies
Here is an update on five different studies featured at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics center on possible newer treatment regimens in both Hodgkin and Burkitt lymphomas, relapsed or refractory chronic lymphocytic leukemia, and newly...
Circulating Tumor Cells May Predict Late Recurrence in Hormone Receptor–Positive Breast Cancer
In patients with early breast cancer, the presence in the blood of circulating tumor cells 5 years after diagnosis increases the risk for recurrence nearly 20-fold, researchers reported at the 2017 San Antonio Breast Cancer Symposium.1 “We found that a single positive circulating tumor cell assay...
Power of Pathologic Complete Response to Neoadjuvant Therapy Demonstrated in I-SPY 2 Trial
More evidence of the power of pathologic complete response (pCR) now comes from an update of the multicenter, adaptively randomized I-SPY 2 trial. In a study reported at the 2017 San Antonio Breast Cancer Symposium, pCR predicted for event-free and distant disease–free survival in high-risk...
NSABP B-47: No Benefit for Adjuvant Trastuzumab in HER2-Low Breast Cancer
For more than a decade, breast cancer experts have wondered whether women with low levels of HER2 might derive some benefit from trastuzumab (Herceptin), based on signals seen in earlier trastuzumab trials. Most notably, in the landmark National Surgical Adjuvant Breast and Bowel Project (NSABP) ...
Expert Point of View: Laurie Sehn, MD and Kenneth C. Anderson, MD
“We don’t think a lot about cutaneous T-cell lymphoma because it is one of the rare forms of lymphoma that we treat, but it is an extremely debilitating type of lymphoma,” said press briefing moderator Laurie Sehn, MD, Chair of the Lymphoma Tumour Group of the British Columbia Cancer Agency in...
Mogamulizumab in Cutaneous T-Cell Lymphoma
The anti-CCR4 monoclonal antibody mogamulizumab may answer an unmet need in providing an effective treatment of cutaneous T-cell lymphoma. In the phase III MAVORIC trial reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, treatment with mogamulizumab was...
Presurgical Targeted Therapy Delays Relapse of High-Risk Stage III Melanoma
A pair of targeted therapies given before and after surgery for melanoma produced at least a sixfold increase in time to progression compared to standard-of-care surgery for patients with stage III disease, Amaria et al reported in The Lancet Oncology. Patients who had no sign of disease at surgery ...
ECHELON-1: A Commendable Study, but Questions Remain
“The important thing is not to stop questioning. Curiosity has its own reason for existing.” —Albert Einstein The phase III international ECHELON-1 study, designed to evaluate brentuximab vedotin (Adcetris) as part of a front-line chemotherapy regimen for previously untreated advanced classic...
Expert Point of View: Howard “Skip” Burris III, MD, FACP, FASCO and Harold Burstein, MD, PhD, FASCO
Howard “Skip” Burris III, MD, FACP, FASCO, Chief Medical Officer and President of Clinical Operations at Sarah Cannon Cancer Center, Nashville, said the antibody-drug conjugates are especially attractive in triple-negative breast cancer. “We know chemotherapy is still effective in a large...
Novel Antibody-Drug Conjugate Active in Refractory Triple-Negative Breast Cancer
In relapsed or refractory triple-negative breast cancer, the antibody-drug conjugate sacituzumab govitecan (IMMU-132) demonstrated significant clinical activity in an open-label study presented at the 2017 San Antonio Breast Cancer Symposium.1 “Metastatic triple-negative breast cancer is an...
Improved Overall and Progression-Free Survival With First-Line Pembrolizumab in Combination With Pemetrexed and Cisplatin or Carboplatin in NSCLC
The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of...
Treatment Outcomes in Patients With Bone Metastasis From Advanced RCC
In a subgroup analysis of the phase III METEOR trial of advanced renal cell carcinoma (RCC) patients with with bone metastases, cabozantinib was associated with improved outcomes vs everolimus. The analysis was reported by Escudier et al in the Journal of Clinical Oncology. Study Details In the...
Chemoradiation in Elderly Patients With Stage III NSCLC Improves Overall Survival
Elderly patients with stage III non–small cell lung cancer (NSCLC) showed improved overall survival when treated with chemoradiation compared to definitive radiation alone, according to findings published by Miller et al in the Journal of Thoracic Oncology. NSCLC constitutes between...
Comparison of Chemoradiation Treatment Schedules in Locally Advanced Head and Neck Cancer
In an Indian phase III trial reported in the Journal of Clinical Oncology, Noronha and colleagues found that curative-intent adjuvant chemoradiotherapy with cisplatin at 100 mg/m2 every 3 weeks produced better locoregional control than cisplatin at 30 mg/m2 every week in patients with locally...
Adjuvant Pembrolizumab Improves Recurrence-Free Survival in Stage III Resected High-Risk Melanoma
On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...
Addition of Tumor-Treating Fields to Maintenance Temozolomide in Glioblastoma
Final results of a phase III trial reported by Stupp and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved progression-free and overall survival in patients with previously treated glioblastoma. The...
FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...
IMvigor211 Trial: Atezolizumab vs Chemotherapy in Platinum-Treated Advanced Urothelial Carcinoma
The phase III IMvigor211 trial showed no survival benefit for atezolizumab (Tecentriq) vs physician's choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma with programmed death-ligand 1 (PD-L1) expression ≥ 5%. Findings were reported in The Lancet by...
Surveillance vs Metastasis-Directed Therapy in Recurrent Oligometastatic Prostate Cancer
In a Belgian phase II study reported in the Journal of Clinical Oncology, Ost et al found that androgen deprivation therapy (ADT)-free survival was prolonged with metastasis-directed therapy vs surveillance in recurrent oligometastatic prostate cancer. Study Details Sixty-two patients with...
Ribociclib Receives FDA Breakthrough Therapy Designation in Premenopausal Women With Hormone Receptor–Positive, HER2-Negative Breast Cancer
On January 3, ribociclib (Kisqali) received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with...
FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...
Dual HER2 Inhibition Plus Aromatase Inhibitor in Metastatic Breast Cancer
The phase III ALTERNATIVE trial has shown progression-free survival benefit with the addition of lapatinib (Tykerb) to trastuzumab (Herceptin) and an aromatase inhibitor among postmenopausal women with HER2-positive, hormone receptor–positive metastatic breast cancer. These findings were...
FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma
On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...
Durvalumab Consolidation After Chemoradiotherapy Improves Progression-Free Survival in Stage III Non–Small Cell Lung Cancer
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1) ...
Durvalumab Consolidation After Chemoradiotherapy Improves Progression-Free Survival in Stage III Non–Small Cell Lung Cancer
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1)...
Lower Dose of Cabazitaxel in Prostate Cancer
On September 14, 2017, the microtubule inhibitor cabazitaxel (Jevtana) was approved at the lower dose of 20 mg/m2 every 3 weeks in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.1,2...
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five members were...
Association of Systemic Inflammation and Sarcopenia With Survival in Colorectal Cancer
Results from the C SCANS (Colorectal Cancer: Sarcopenia, Cancer, and Near-Term Survival) study indicate that prediagnosis systemic inflammation and at-diagnosis sarcopenia are associated with an increased mortality risk in patients with nonmetastatic colorectal cancer. The findings were reported...
Dyadic Yoga Program for Patients With Lung Cancer and Their Caregivers May Optimize Treatment Response
Yoga therapy delivered to patients with lung cancer and their caregivers together appears to be a feasible and beneficial supportive care strategy. According to data presented at the 2017 Palliative and Supportive Care in Oncology Symposium,1 the dyadic intervention resulted in a clinically and...
Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer
As reported in The Lancet by Krishnansu S. Tewari, MD, of the University of California-Irvine Medical Center, and colleagues, the final overall survival results of the phase III Gynecologic Oncology Group 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in...
Brentuximab Vedotin for Adult Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
On November 9, 2017, brentuximab vedotin (Adcetris) received regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.1,2 Supporting Efficacy Data Approval was based on...
Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...
Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer
On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved...
PI3K Inhibition With Copanlisib in Relapsed or Refractory Indolent Lymphoma
AS REPORTED in the Journal of Clinical Oncology by Martin Dreyling, MD, PhD, of University Hospital, Ludwig Maximilians University of Munich, and colleagues, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor...
Obinutuzumab in Previously Untreated Follicular Lymphoma
On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...
Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies
In the not-so-distant past, clinical trials were considered an option only for the young and fit. Enrolling older people “used to be thought unethical,” said Janet Woodcock, MD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), as she opened...
Disease Progression and Deterioration of Health-Related Quality of Life in Advanced Breast Cancer
IN PATIENTS WITH estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer, better quality of life may be prolonged by delaying the progression of the disease, according to an ongoing quality-of-life assessment from the PALOMA-2 study, presented by Nadia Harbeck, MD, PhD, of...
Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
On November 16, 2017, sunitinib malate (Sutent) was approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.1,2 Supporting Efficacy Data Approval was based on the findings of the double-blind phase III S-TRAC trial in which 615...
